The invention relates to a one-piece dispensing device for contamination-free administration of medicaments (cytostatica), particularly for use in ambulant treatment.
For mixing and transferring pharmaceutical solutions from one container to at least another one it is required to embody the connection in such a manner that an escape of pharmaceutic agents and, thus, a contamination of the container surface and of the health care workers is eliminated. In particular, with respect to the mixing and administration of highly toxic cytostatic solutions, which can cause diseases when escaping uncontrolled, a contamination-free transfer and mixing is required.
According to the state of art, an infusion solution and dry or liquid form drugs are admixed by a syringe and by removal from and addition to different containers, before a mixed infusion solution is ready for infusion. Contaminations cannot be eliminated due to pressure differentials between the different containers and the atmosphere, and due to the free handling of the syringe. Such a practice requires working under a suction apparatus which is considerably disturbing in medical work.
Furthermore, injection ports on infusion containers have been proposed which improve the mixing of the agents mentioned but do not eliminate the problem of contamination. A further improvement of the same object is known from the EP 0 363 770 A1 which discloses a connector for pharmaceutic solutions, and from EP 0 330 130 which disclose a container for infusion solutions. The connector described in the EP 0 363 770 substantially consists of a tubular coupling portion and a shutoff device for closing the former. The coupling portion is comprised of a hollow insertion pin and a hollow portion attached thereto which permits insertion into a hose-like connector of a container. The hollow portion is closed by a stop-cock detachable from the outside. However, even when employing containers having rubber stopper seals, elimination emission of aerosols is not assured.
Furthermore, connectors are known from the U.S. Pat. No. 4,675,020 and from the EP 0 028 198 which do not solve the problem of contamination as desired and, additionally, similar to the above disclosed device, only permit the connection of two containers filled with pharmaceutic solutions. Thus, such devices are only applicable when, for example, the dissolving of an agent requires two solvents.